1. Field of the Invention
The present invention relates to a new composition of etofibrate microgranules which are differently formulated and differently manufactured in comparison to the already available product.
2. Description of the Prior Art
Etofibrate is in fact a known compound having the following pharmacological properties: it reduces hyperlipidemia, hypertriglyceridemia and hypercholesterolemia.
Said etofibrate is a compound corresponding to the chemical name 2-(p-chlorophenoxy)-2-methylpropionic acid [2-(nicotinoyloxy)-ethyl]-ester. This product is on the market since many years and is available in form of hard "00" type gelatine capsules containing 500 mg of etofibrate as sustained release microgranules. These capsules, with a capacity of 0.95 ml, are able to contain the above microgranules which are composed of an inert material inner core coated with a spheroidal layer of active ingredient comprising etofibrate and polyethylene glycol 4000, also known on the market as polyglycol 4000. This result, that has been achieved by means of particular per se known processes, entails each microgranule to have a concentration ranging from 67 to 75% of active ingredient, as even each microgranule consists also of an inert material inner core with a diameter of 850-500 microns comprising from 65 to 90% of sucrose and from 10 to 35% of corn starch. The presence in each microgranule of an inner core binds evidently to use the above "00" type of capsules, being only these capsules able to contain the mentioned dosage of 500 mg per capsule.